Valneva Se · EURONEXT:VLA
Valneva — Shareholder Meeting (June 2018)
64 slides from Valneva's shareholder meeting presentation, Jun 28, 2018
Slide 1: Annual General Meeting Valneva SE
Annual General Meeting Valneva SE June 28, 2018 Lyon
Slide 2: Forward-looking statements
Forward-looking statements This presentation contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing and completion of research, development and clinical trials for product candidates, the ability to manufacture, market, commerc
Slide 3: Agenda
Agenda 1. AGM preliminary formalities 2. Introduction 3. Company overview 4. 2017 business highlights & recent newsflow 5. Valneva 2017 financials & outlook 6. Answers to written questions 7. Auditor’s reports 8. Presentation and discussion of resolutions; voting 9. Conclusion VALNEVA - Annual Gener
Slide 4: AGM preliminary formalities
AGM preliminary formalities Sign attendance sheet (all) Appoint AGM committee (chairman, observers, secretary) Validation of the Quorum (secretary) Agenda (chairman) Documents filed with the AGM committee (secretary) VALNEVA - Annual General Meeting June 28, 2018 4
Slide 5: Agenda
Agenda 1. AGM preliminary formalities 2. Introduction 3. Company overview 4. 2017 business highlights & recent newsflow 5. Valneva 2017 financials & outlook 6. Answers to written questions 7. Auditor’s reports 8. Presentation and discussion of resolutions; voting 9. Conclusion VALNEVA - Annual Gener
Slide 6: Agenda
Agenda 1. AGM preliminary formalities 2. Introduction 3. Company overview 4. 2017 business highlights & recent newsflow 5. Valneva 2017 financials & outlook 6. Answers to written questions 7. Auditor’s reports 8. Presentation and discussion of resolutions; voting 9. Conclusion VALNEVA - Annual Gener
Slide 7: Valneva has two main value drivers
Valneva has two main value drivers Combination of strong revenues and high value R&D assets Repeated double digit product sales growth A valuable R&D pipeline (15% in 2017) Product sales €92.6m DUKORAL® €28.5mOther Direct sales Total revenues IXIARO®/ 73.5% and grants JESPECT® €109.8m €60.0m TPP* +1
Slide 8: Valneva's 2022 strategy
Valneva’s 2022 strategy To become the leading fully-integrated commercial stage vaccine biotech company Products R&D Growing revenues from Investing in innovative R&D existing and future programs to meet unmet products to €200m and medical needs beyond Financials Growth Achieving financial Generatin
Slide 9: Valneva's pipeline
Valneva’s pipeline Focusing on vaccines with high unmet medical need Product Candidate Discovery Pre-clinical IND Phase 1 Phase 2 Phase 3 Market Partner research research enabling Japanese Marketed vaccines Encephalitis Cholera (ETEC1) Clostridium TBD difficile Clinical candidates Lyme disease propr
Slide 10: Agenda
Agenda 1. AGM preliminary formalities 2. Introduction 3. Company overview 4. 2017 business highlights & recent newsflow 5. Valneva 2017 financials & outlook 6. Answers to written questions 7. Auditor’s reports 8. Presentation and discussion of resolutions; voting 9. Conclusion VALNEVA - Annual Gener
Slide 11: Valneva 2017 performance at a glance
Valneva 2017 performance at a glance A strong year for Valneva ✔ Delivered on + Sales +15% vs. 2016 financial targets + EBITDA €10.8m vs. €2.8m in 2016 ✔ Executed well + Increased product adoption in main markets on key growth drivers + Additional IXIARO® supply contract with US government + Took ov
Slide 12: Valneva continued to deliver in H1 2018
Valneva continued to deliver in H1 2018 February 26, 2018 Zika: Emergent BioSolutions and Valneva Initiate Phase 1 Clinical Study to evaluate their vaccine candidate VLA1601 March 13, 2018 Chikungunya: Valneva initiates Phase 1 clinical study to evaluate its single-shot vaccine candidate VLA1553 Mar
Slide 13: IXIARO/JESPECT: The only JE vaccine approved in the US and Europe
IXIARO®/JESPECT® The only JE vaccine approved in the US and Europe Japanese Encephalitis vaccine + Designed to protect travelers and military against JE + Indicated for active immunization against JE in adults, adolescents, children and infants aged two months and older1 Commercial position Market p
Slide 14: IXIARO/JESPECT: Ongoing double digit sales growth and increasing margin
IXIARO®/JESPECT® Ongoing double digit sales growth and increasing margin 2016 2017 2020 2016 2017 2020 IXIARO®/JESPECT® sales US is the biggest contributor Gross margin (in €m) to top line CAGR CAGR >15% 10% Other countries 25% ~70% US military 46% 64% Germany 10% 60% 60.0 53.0 UK 10% US private 9%
Slide 15: DUKORAL: The only cholera vaccine available in EU, Canada & Australia
DUKORAL® The only cholera (ETEC1) vaccine available in EU, Canada & Australia DUKORAL® + For the prevention of diarrhea caused by Vibrio cholera (cholera) and/or heat-labile toxin producing enterotoxigenic Escherichia coli (ETEC)1 + In several markets, including EU, currently indicated to protect ag
Slide 16: DUKORAL: Excellent sales growth in key markets
DUKORAL® Excellent sales growth in key markets 2016 2017 2020 2016 2017 2020 DUKORAL® sales (in €m) Canada is the biggest Gross margin contributor CAGR CAGR 10-15% 5-10% Other countries 23% 28.5 24.6 >55% UK 7% Canada 54% >46% Nordics 16% 46% Split of 2017 product sales 2016 2017 2020 2016 2017 2020
Slide 17: VLA15: the only Lyme disease vaccine in clinical development
VLA15: the only Lyme disease vaccine in clinical development Market potential of approximately €700m - €800m1 Lyme disease Valneva’s vaccine candidate + Transmitted by Ixodes ticks2, causing Lyme + Only active clinical program, no vaccine on the market + Most common vector borne illness in the North
Slide 18: VLA15 (Lyme): Phase 1 study
VLA15 (Lyme): Phase 1 study Positive initial results reported Q1 2018 Conducted in 179 subjects in US and EU (www.clinicaltrials.gov, identifier NCT03010228): Study primary endpoint met + Favorable safety profile + No safety concerns associated with VLA15 in any treatment group1 Encouraging immunoge
Slide 19: VLA1553: Chikungunya vaccine candidate
VLA1553: Chikungunya vaccine candidate A potential single-shot vaccine against a severe, growing threat Chikungunya Valneva’s vaccine candidate Mosquito-borne + Transmitted viral disease by Aedes caused mosquitoes, by the causing + Monovalent, single dose, live Chikungunya virus Chikungunya disease
Slide 20: VLA1553: Chikungunya vaccine candidate, Phase 1 study design
VLA1553: Chikungunya vaccine candidate, Phase 1 study design Blinded, randomized, dose-escalation study in ~120 participants VALNEVA - Annual General Meeting June 28, 2018 20
Slide 21: VLA1601: Zika vaccine candidate
VLA1601: Zika vaccine candidate Valneva and Emergent BioSolutions partnership Zika Valneva’s vaccine candidate + Zika is a mosquito-borne viral disease, a Flavivirus + Highly purified inactivated transmitted by Aedes mosquitoes1 whole-virus vaccine (PIV) + Most common symptoms are flu-like symptoms
Slide 22: Agenda
Agenda 1. AGM preliminary formalities 2. Introduction 3. Company overview 4. 2017 business highlights & recent newsflow 5. Valneva 2017 financials & outlook 6. Answers to written questions 7. Auditor’s reports 8. Presentation and discussion of resolutions; voting 9. Conclusion VALNEVA - Annual Gener
Slide 23: Full Year 2017 Profit & Loss
Full Year 2017 Profit & Loss Strong sales and EBITDA performance €m 12 months ended December 31 2017 2016 Revenues and grants 109.8 97.9 Cost of goods and services (46.0) (43.1) R&D expenses (23.4) (24.6) Distribution and marketing expenses (17.9) (16.6) General and administrative expenses (15.5) (1
Slide 24: Full Year Revenue analysis 2015 - 2017
Full Year Revenue analysis 2015 - 2017 €m 2018 2015 2016 2017 Guidance Product sales revenues IXIARO®/JESPECT® 30.6 53.0 60.0 DUKORAL® 21.0 24.6 28.5 Third party products 9.9 2.9 4.0 Total products 61.5 80.4 92.6 > 100 Other revenues 16.8 13.6 12.7 Grants / R&D tax credits 5.0 3.8 4.5 Total revenues
Slide 25: Strong cash position at end 2017
Strong cash position at end 2017 boosted by positive cash flow Cash (€m) Working capital (€m) 52.3 42.2 45.8 38.1 FY 2017 FY 2016 FY 2017 FY 2016 Net debt (€m) Operating cash-flow (€m) 33.4 40.3 12.8 6.5 FY 2017 FY 2016 FY 2017 FY 2016 VALNEVA - Annual General Meeting June 28, 2018 25
Slide 26: 2018 Financial Outlook
2018 Financial Outlook Continued double-digit sales growth and positive EBITDA, higher R&D investment driven by clinical development progression 2017 Actual 2018 Outlook Growth Product sales €92.6m > €100m > 10% R&D investment €23.4m €30 – 35m N/A EBITDA €10.8m €5 – 10m N/A Total revenues and grants
Slide 27: Valneva 2018 – Exciting upcoming newsflow
Valneva 2018 – Exciting upcoming newsflow + Further product sales growth during the year + New IXIARO® supply contract with US DoD expected in Q4 + H1 results 2nd August + Lyme Phase 2 initiation expected by end of year + Execution of Chikungunya Phase 1 study in the US + Execution of Zika Phase 1 s
Slide 28: Agenda
Agenda 1. AGM preliminary formalities 2. Introduction 3. Company overview 4. 2017 business highlights & recent newsflow 5. Valneva 2017 financials & outlook 6. Answers to written questions 7. Auditor’s reports 8. Presentation and discussion of resolutions; voting 9. Conclusion VALNEVA - Annual Gener
Slide 29: Agenda
Agenda 1. AGM preliminary formalities 2. Introduction 3. Company overview 4. 2017 business highlights & recent newsflow 5. Valneva 2017 financials & outlook 6. Answers to written questions 7. Auditor’s reports 8. Presentation and discussion of resolutions; voting 9. Conclusion VALNEVA - Annual Gener
Slide 30: Statutory and Consolidated financial statements 2017
Statutory and Consolidated financial statements 2017 Opinion from the Auditors + On the consolidated financial statements (Excerpt of the Auditors report on the consolidated accounts, March 21, 2018) “In our opinion, the consolidated financial statements give a true and fair view of the assets and l
Slide 31: Related-party agreements and commitments
Related-party agreements and commitments Excerpt from the Statutory Auditors’ report + Agreements and commitments authorized during the year 2017 Management Agreement executed between Valneva SE and Mr. David Lawrence, Management Board member & CFO (authorized by the Supervisory Board on August 1,
Slide 32: Related-party agreements and commitments
Related-party agreements and commitments Excerpt from the Statutory Auditors’ report + Agreements and commitments authorized during the year 2017 Indemnities granted to Mr. Reinhard Kandera upon termination of his offices as Management Board member – Chief Financial Officer of the Valneva Group (a
Slide 33: Related-party agreements and commitments
Related-party agreements and commitments Excerpt from the Statutory Auditors’ report + Agreements and commitments approved in previous years and continued in 2017 Agreement with Franck Grimaud, member of the Management Board and Deputy Chief Executive Officer (authorized by the Supervisory Board o
Slide 34: Agenda
Agenda 1. AGM preliminary formalities 2. Introduction 3. Company overview 4. 2017 business highlights & recent newsflow 5. Valneva 2017 financials & outlook 6. Answers to written questions 7. Auditor’s reports 8. Presentation and discussion of resolutions; voting 9. Conclusion VALNEVA - Annual Gener
Slide 35: Important note on resolutions
IMPORTANT NOTE: Some of the resolutions shown on the following slides have been summarized. For the full text and for voting purposes, please refer to Valneva’s website www.valneva.com or to the print-outs that have been distributed. The English resolutions and their English summary are free transla
Slide 36: Resolution 1 - Approval of statutory financial statements
Resolution 1 - Approval of the statutory financial statements for the year ended December 31, 2017 The Shareholders, acting in accordance with the quorum and majority voting requirements applicable to Ordinary General Meetings of Shareholders, after having reviewed the separate financial statements
Slide 37: Resolution 2 - Approval of consolidated financial statements
Resolution 2 - Approval of consolidated financial statements for the year ended December 31, 2017 The Shareholders, acting in accordance with the quorum and majority voting requirements applicable to Ordinary General Meetings of Shareholders, after having reviewed the consolidated financial statemen
Slide 38: Resolution 3 - Discharge of Management and Supervisory Board
Resolution 3 - Discharge of Management Board and Supervisory Board members for the performance of their duties The Shareholders, acting in accordance with the quorum and majority voting requirements applicable to Ordinary General Meetings, after having reviewed the reports of the Management Board, t
Slide 39: Resolution 4 - Appropriation of earnings
Resolution 4 - Appropriation of earnings for the year ended December 31, 2017 The Shareholders, acting in accordance with the quorum and majority voting requirements applicable to Ordinary General Meetings, resolve to allocate to retained earnings (accumulated deficit) or the total loss of fifteen m
Slide 40: Resolution 5 - Regulated agreements with Groupe Grimaud La Corbière
Resolution 5 - Approval of regulated agreements and commitments governed by articles L. 225-86 et seq. of the Commercial code, entered into with Groupe Grimaud La Corbière SA The Shareholders, acting in accordance with the quorum and majority requirements applicable to Ordinary General Meetings, aft
Slide 41: Resolution 6 - Other regulated agreements
Resolution 6 - Approval of other regulated agreements and commitments governed by articles L. 225-86 et seq. of the Commercial code The Shareholders, acting in accordance with the quorum and majority requirements applicable to Ordinary General Meetings, after having reviewed the Statutory Auditors’
Slide 42: Resolution 7 - Compensation principles, Management Board
Resolution 7 - Approval of the principles and criteria for setting, allocating and granting fixed, variable and special compensation making up the total compensation and benefits of any kind granted to the Chairman and the members of the Management Board The Shareholders, acting in accordance with t
Slide 43: Resolution 8 - Compensation principles, Supervisory Board
Resolution 8 - Approval of the principles and criteria for setting, allocating and granting fixed, variable and special compensation making up the total compensation and benefits of any kind granted to the Chairman and the members of the Supervisory Board The Shareholders, acting in accordance with
Slide 44: Resolution 9 - Compensation of Thomas Lingelbach
Resolution 9 - Approval of the fixed, variable and special compensation making up the total compensation and benefits of any kind paid or granted to Mr. Thomas Lingelbach, Chairman of the Management Board, in respect of the financial year ended December 31, 2017 The Shareholders, acting in accordanc
Slide 45: Resolution 10 - Compensation of Management Board members
Resolution 10 - Approval of the fixed, variable and special compensation making up the total compensation and benefits of any kind paid or granted to the members of the Management Board (other than the Chairman) in respect of the financial year ended December 31, 2017 The Shareholders, acting in acc
Slide 46: Resolution 11 - Compensation of Frédéric Grimaud
Resolution 11 - Approval of the fixed, variable and special compensation making up the total compensation and benefits of any kind paid or granted to Mr. Frédéric Grimaud, Chairman of the Supervisory Board, in respect of the financial year ended December 31, 2017 The Shareholders, acting in accordan
Slide 47: Resolution 12 - Share buyback authorization
Summary of resolution 12 - Authorization and powers to be given to the Management Board for the purpose of allowing the Company to make transactions on its own shares The Company may, during a period of 18 months as from this Meeting: + buy-back its own shares up to a maximum of 5% of the share capi
Slide 48: Resolution 13 - Change of registered office
Resolution 13 - Change of registered office The Shareholders, acting in accordance with the quorum and majority requirements applicable to Ordinary General Meetings, after having reviewed the report of the Management Board, decide to move the Company’s registered office from World Trade Center Lyon
Slide 49: Resolution 14 - Cancel treasury shares
Summary of resolution 14 - Authorization granted to the Management Board to cancel treasury shares The Shareholders authorize the Management Board, for a period of eighteen months from this meeting, to cancel, at its sole discretion, on one or more occasions, any Company shares acquired by the Compa
Slide 50: Resolution 15 - Capital increase with preferential rights
Summary of resolution 15 - Granting of authority to the Management Board to increase the share capital by issuing ordinary shares or any securities giving access to the capital while maintaining the preferential subscription right The Shareholders: + delegate to the Management Board, for a maximum p
Slide 51: Resolution 16 - Capital increase by public offering
Summary of resolution 16 - Granting of authority to the Management Board to increase the capital by issuing ordinary shares and all securities conferring rights to the capital, through a public offering, canceling preferential subscription rights, while including an option for a priority period The
Slide 52: Resolution 17 - Capital increase by private placement
Summary of resolution 17 - Granting of authority to the Management Board to increase the share capital by issuing shares and/or securities giving present and/or future access to the Company's share capital through private placement, with cancellation of preferential subscription rights The Sharehold
Slide 53: Resolution 18 - Increase number of securities issued
Resolution 18 - Granting of authority to the Management Board to increase the number of securities to be issued in connection with a share capital increase with or without preferential subscription right, up to the limit of 15% of the initial issue The Shareholders: + resolve, in accordance with the
Slide 54: Resolution 19 - Capitalization of reserves
Summary of resolution 19 - Granting of authority to the Management Board in order to increase the share capital through the capitalization of reserves, earnings or premium The Shareholders: + resolve, in accordance with the provisions of L. 225-129-2 of the French commercial code, to grant the Manag
Slide 55: Resolution 20 - Issue price setting
Summary of resolution 20 - Granting of authority to the Management Board in order to implement the issue of Company ordinary shares and/or securities giving immediate and/or later access to the capital of the Company with cancellation of preferential subscription rights, and to set the issue price i
Slide 56: Resolution 21 - Contributions in kind
Summary of resolution 21 - Granting of authority to the Management Board to increase the share capital by issuing shares and/or securities giving immediate and/or future access to the capital of the Company, in consideration for contributions in kind for equity securities or other securities giving
Slide 57: Resolution 22 - Maximum aggregate capital increases
Resolution 22 - Maximum aggregate amount of capital increases The Shareholders, acting in accordance with the conditions of quorum and majority that apply at Extraordinary Shareholders Meetings, after having reviewed the Management Board report, and subject to the adoption of resolutions fifteen to
Slide 58: Resolution 23 - Stock options
Summary of resolution 23 - Granting of authority to the Management Board for the purpose of granting stock options, through one or more issues, for the benefit of employees and/or corporate officers of the Company and its affiliates, entailing waiver by shareholders of their preferential subscriptio
Slide 59: Resolution 24 - Issue of equity warrants
Summary of resolution 24 - Issue of equity warrants The Shareholders resolve, subject to approval of resolution 25, to issue 57,500 detachable equity warrants of the Company (“BSA 29”). + Form: Registered + Term : 5 years + Freely transferable + Issue price: 10% of volume-weighted average price of o
Slide 60: Resolution 25 - Cancellation of preferential subscription rights
Resolution 25 - Cancellation of preferential subscription rights for the benefit of selected categories of persons The Shareholders, acting in accordance with the conditions of quorum and majority that apply at Extraordinary General Meetings, after having reviewed the report of the Management Board
Slide 61: Resolution 26 - Capital increase reserved for employees
Summary of resolution 26 - Granting of authority to the Management Board for the purpose of deciding to carry out a capital increase reserved for employees The Shareholders: + resolve in accordance with the provisions of article L. 225-129-6 of the French commercial to reserve for the benefit of emp
Slide 62: Resolution 27 - Powers for formalities
Resolution 27 - Powers for formalities The Shareholders grant all powers to the holder of an original copy, an excerpt or a copy of these minutes certified as authentic to carry out all necessary processes, filings and formalities or as required by operation of law. VALNEVA - Annual General Meeting
Slide 63: Agenda
Agenda 1. AGM preliminary formalities 2. Introduction 3. Company overview 4. 2017 business highlights & recent newsflow 5. Valneva 2017 financials & outlook 6. Answers to written questions 7. Auditor’s reports 8. Presentation and discussion of resolutions; voting 9. Conclusion VALNEVA - Annual Gener
Slide 64: Thank you.
Thank you. WAvalneva